- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989687
Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under <10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention.
The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suzanne E Fournier, DDS
- Phone Number: 504-941-8199
- Email: sfour1@lsuhsc.edu
Study Contact Backup
- Name: Daniel Kim, 'DMD
- Phone Number: 504-941-8199
- Email: dkim5@lsuhsc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects.
-
Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects,
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: glass ionomer sealant
|
rubber dam or cotton roll isolation
|
Experimental: isolation
isolation type either rubber dam or cotton roll isolation
|
glass ionomer sealant
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
retention rate of sealants
Time Frame: 6 months
|
retention rate for sealants placed with different modes of isolation
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Suzanne Fournier, DDS, LSUHSC
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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